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Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) - DEVOTE 1
Plain-language guide to PMID 27595693 (2016): double-blind randomized controlled trial study of Insulin Glargine in 7,637 patients.
Key Facts
- PMID
- 27595693
- Journal
- American heart journal
- Year
- 2016
- Study type
- Randomized Controlled Trial
- Authors
- Marso SP et al. (12 authors)
- DOI
- 10.1016/j.ahj.2016.06.004
- Registered trial
- NCT01959529
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at Insulin Glargine.
DEVOTE was designed to evaluate the cardiovascular safety of insulin degludec (IDeg) vs insulin glargine U100 (IGlar) in patients with T2D at high risk of cardiovascular events.
Why It Was Studied
DEVOTE is a phase 3b, multicenter, international, randomized, double-blind, active comparator-controlled trial, designed as an event-driven trial that would continue until 633 positively adjudicated primary events were accrued.
Who Took Part
According to the abstract, 7,637 patients were involved.
PubMed indexes the participants as middle-aged adults and older adults, both men and women.
Patients with T2D at high risk of cardiovascular complications were randomized 1:1 to receive either IDeg or IGlar, each added to background therapies.
How the Study Was Run
The design is described as randomized, double-blind and multicenter.
Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Neither the patients nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.
Running at several centres spread the Insulin Glargine study over different clinics and patient groups.
What Was Measured
DEVOTE is a phase 3b, multicenter, international, randomized, double-blind, active comparator-controlled trial, designed as an event-driven trial that would continue until 633 positively adjudicated primary events were accrued.
The subject headings attached to it are Angina, Unstable, Cardiovascular Diseases, Comorbidity, Coronary Disease, Diabetes Mellitus, Type 2, Glycated Hemoglobin and Heart Failure.
What This Means in Plain Language
The paper is a randomized, double-blind and multicenter study of Insulin Glargine in 7,637 patients.
With several hundred people or more, it is a fairly large study for this kind of research.
The publication is from 2016 (American heart journal), a journal based in United States.
More context: the Insulin Glargine compound page.
Our Notes on the Compound
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.